DP 8-制剂生产副高级工程师/高级工程师

生产组织与技术支持 负责无菌制剂生产全过程的组织与实施，包括配液、灌装、灯检等关键生产环节，确保生产活动安全、高效、合规开展。 Manufacturing Execution & Technical Support Lead and support aseptic drug product manufacturing activities, including formulation, filling and visual inspection, ensuring safe, efficient, and compliant operations. 工艺优化与持续改进 负责生产工艺优化、生产效率提升及技术问题解决，推动生产过程持续改进，提高产品质量和运营效率。 Process Optimization & Continuous Improvement Drive process optimization initiatives, troubleshoot manufacturing issues, and continuously improve product quality, operational efficiency, and manufacturing performance. 设备管理与技术提升 负责关键生产设备的技术管理，参与设备选型、验证、维护及生命周期管理，确保设备持续满足生产需求。 Equipment Management & Technical Enhancement Support equipment selection,

, maintenance, and lifecycle management to ensure manufacturing equipment remains fit for intended use. 质量与合规管理 负责偏差调查、变更控制、CAPA执行及风险评估等工作，推动问题分析和整改措施落实，确保符合GMP及法规要求。 Quality & Compliance Management Lead deviation investigations, change controls, CAPA implementation, and risk assessments to ensure compliance with GMP and regulatory requirements. 文件管理与项目支持 负责生产相关文件、工艺文件及技术报告的审核与编制，参与工艺转移、验证及客户项目实施工作。 Documentation & Project Support Review and prepare manufacturing documents, technical reports, and process records, while supporting technology transfer, validation, and customer project execution. 团队培养与知识传承 负责生产人员的技术培训、现场指导和能力提升，推动标准化操作和知识经验分享。 Team Development & Knowledge Sharing Provide technical coaching, on-the-job training, and knowledge sharing to enhance team capabilities and promote operational excellence. 任职要求 Qualifications 教育背景 制药、生物工程、药学、生物技术等相关专业本科及以上学历。 Education Bachelor's degree or above in Pharmaceutical Sciences, Biological Engineering, Pharmacy, Biotechnology, or related disciplines. 专业经验 本科具有8年以上或硕士具有5年以上制药行业相关工作经验，具备丰富的无菌制剂生产经验。 Professional Experience Bachelor's degree holders with at least 8 years of relevant pharmaceutical industry experience, or Master's degree holders with at least 5 years of relevant experience, preferably in aseptic drug product manufacturing. 技术能力 精通无菌制剂生产工艺及关键控制要求，能够独立解决复杂生产技术问题并推动工艺持续优化。 Technical Expertise In-depth knowledge of aseptic drug product manufacturing processes and critical process controls, with the ability to independently resolve complex technical issues and drive process improvements. 设备知识 熟悉无菌制剂生产设备及其运行原理。 Equipment Knowledge Extensive knowledge of aseptic manufacturing equipment and operating principles. 项目与协调能力 具备良好的跨部门沟通协调能力，能够组织推动工艺转移、验证及生产改善项目顺利实施。 Project & Collaboration Skills Strong cross-functional collaboration and coordination skills, with experience supporting technology transfer, validation, and manufacturing improvement projects. 办公与综合能力 熟练使用Office等办公软件，具备较强的数据分析、问题解决、团队协作及执行能力。 Computer Skills & Core Competencies Proficient in Microsoft Office applications, with strong analytical, problem-solving, teamwork, and execution skills. 英语能力 具备良好的英语读写能力，能够阅读和理解英文技术文件、设备操作手册及质量体系文件；具备基本的英文沟通能力者优先。 English Proficiency Good English reading and writing skills, with the ability to understand technical documents, equipment manuals, and quality system documentation in English. Basic verbal communication skills in English are preferred.